| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N214275-001 | UPTRAVI | SELEXIPAG | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 |
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N214275-001 | 7205302 | 2026-10-31 | U-1797 | Drug substance, Drug product | 2021-08-27 |
| N214275-001 | 7205302*PED | 2027-04-30 | Pediatric extension | ||
| N214275-001 | 9173881 | 2029-08-12 | U-1798 | 2021-08-27 | |
| N214275-001 | 9173881*PED | 2030-02-12 | Pediatric extension | ||
| N214275-001 | 9284280 | 2030-06-25 | U-1831 | 2021-08-27 | |
| N214275-001 | 8791122 | 2030-08-01 | Drug substance, Drug product | 2021-08-27 | |
| N214275-001 | 9284280*PED | 2030-12-25 | Pediatric extension | ||
| N214275-001 | 8791122*PED | 2031-02-01 | Pediatric extension |
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| UPTRAVI | SELEXIPAG | Actelion Pharmaceuticals US, Inc. | a7a23b87-f892-4e2c-8e2e-ebf841220f90 | 2026-05-28 | Warnings, Adverse reactions |
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
5 WARNINGS AND PRECAUTIONS Pulmonary edema in patients with pulmonary veno-occlusive disease. If confirmed, discontinue treatment. ( 5.1 ) 5.1 Pulmonary Edema with Pulmonary Veno-Occlusive Disease Should signs of pulmonary edema occur, consider the possibility of associated pulmonary veno-occlusive disease. If confirmed, discontinue UPTRAVI.
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
6 ADVERSE REACTIONS Adverse reactions in adult and pediatric patients occurring more frequently (≥5%) on UPTRAVI compared to placebo are headache, diarrhea, jaw pain, nausea, myalgia, vomiting, pain in extremity, and flushing. Additional adverse reaction occurring in pediatric patients more frequently (≥5%) on UPTRAVI compared to placebo is abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Actelion at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. UPTRAVI Tablets Adult Patients The safety of UPTRAVI tablets has been evaluated in a long-term, placebo-controlled study enrolling 1,156 adult patients with symptomatic PAH (GRIPHON study) [see Clinical Studies (14.1) ] . The exposure to UPTRAVI in this trial was up to 4.2 years with median duration of exposure of 1.4 years. Table 3 presents adverse reactions more frequent on UPTRAVI tablets than on placebo by ≥3%. Table 3: Adverse Reactions UPTRAVI Placebo Adverse Reaction N=575 N=577 Headache 65% 32% Diarrhea 42% 18% Jaw pain 26% 6% Nausea 33% 18% Myalgia 16% 6% Vomiting 18% 9% Pain in extremity 17% 8% Flushing 12% 5% Arthralgia 11% 8% Anemia 8% 5% Decreased appetite 6% 3% Rash 11% 8% These adverse reactions are more frequent during the dose titration phase. Hyperthyroidism was observed in 1% (n=8) of patients on UPTRAVI tablets and in none of the patients on placebo. Pediatric Patients Two Years and Older The safety of UPTRAVI tablets has been evaluated in a long-term, Phase 3, double-blind, placebo-controlled study (SALTO), where a total of 138 pediatric patients with symptomatic PAH ≥2 to
Table 3: Adverse ReactionsUPTRAVIPlaceboAdverse ReactionN=575N=577Headache65%32%Diarrhea42%18%Jaw pain26%6%Nausea33%18%Myalgia16%6%Vomiting18%9%Pain in extremity17%8%Flushing12%5%Arthralgia11%8%Anemia8%5%Decreased appetite6%3%Rash11%8%
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 82595-000-01 | 82595000001 | 1 VIAL in 1 CARTON (82595-000-01) > 1 POWDER, FOR SOLUTION in 1 VIAL | 1 vial | 2021-07-29 | 0000-00-00 | No | No | Current |